FDA 510(k)

InMode RF System

Número K: K182325 · 2018-09-26

Data da decisão2018-09-26

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

InMode RF System is the device name listed in this FDA 510(k) record. The listed applicant is Inmode MD , Ltd.. It received FDA 510(k) clearance on 2018-09-26 under 510(k) number K182325. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the InMode RF System?

InMode RF System is a medical device that received FDA 510(k) clearance on 2018-09-26. The listed applicant is Inmode MD , Ltd.. The 510(k) number is K182325.

When did InMode RF System receive FDA 510(k) clearance?

InMode RF System received FDA 510(k) clearance on 2018-09-26, under 510(k) number K182325.

Who is the listed applicant for InMode RF System?

The FDA 510(k) record lists Inmode MD , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InMode RF System?

The FDA product code for InMode RF System is GEI.

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Outros registros que listam Inmode MD , Ltd. como candidato(a)

K210492InMode RF Pro System K192695InMode System with the Morpheus8 (Fractora) Applicators K191855EmFace Device K183450EmBody System K180719InMode Diolaze System K180189InMode System with Fractora3D/3D-90 Applicators

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Fonte oficial

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